Tamoxifen Citrate

Product NDC
50090-0485
11-digit product format
500900485
Labeler code
50090
Product ID
50090-0485_b4e41027-4beb-46cc-b12d-38fc3b6f357d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamoxifen Citrate
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA070929
Marketing category
ANDA
Marketing start
2011-08-15
Substance
TAMOXIFEN CITRATE
Active strength
10 mg/1
Pharmacologic classes
Estrogen Agonist/Antagonist [EPC], Selective Estrogen Receptor Modulators [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tamoxifen Citrate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TAMOXIFEN CITRATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7FRV7310N6
Rxcui198240

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c3572c17-50b0-db2d-1012-2cc228ccf88fProduct name320201015

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-0485-12023-02-07C16284748780-1f386c64a-044c-0266-e053-dadaa90a7c1aTamoxifen Citrate Tablets, USP Rx o nly
50090-0485-12023-01-30C16284748780-1f386c64a-044c-0266-e053-dadaa90a7c1aTamoxifen Citrate Tablets, USP Rx o nly

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0485-1Tamoxifen Citrate60 in 1 BOTTLETABLET6013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0485-1EA - Each50090-04854c1b1c9d-8329-4483-9679-b0cff09d7d9c12021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0485TAMOXIFEN CITRATE TABLET [A-S MEDICATION SOLUTIONS]11Current NDC, Legacy NDC, 1 package rows20240201_8d731e7e-3b04-49a2-a0f6-3779422174cc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198240tamoxifen citrate 10 MG Oral TabletPSN8d731e7e-3b04-49a2-a0f6-3779422174cc13
198240tamoxifen 10 MG Oral TabletSCD8d731e7e-3b04-49a2-a0f6-3779422174cc13
198240tamoxifen 10 MG (as tamoxifen citrate 15.2 MG) Oral TabletSY8d731e7e-3b04-49a2-a0f6-3779422174cc13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0485-15009004850160 TABLET in 1 BOTTLE (50090-0485-1) 60 tablet2016-06-290000-00-00NoNoCurrent